Terumo Recalls Sarns Cardioplegia Cannula Kits Due to Foreign Substance
Terumo is recalling Sarns Cardioplegia Cannula Kits because a foreign substance was found on the inner surface of some cannula tips that could be dislodged.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a foreign substance that can be dislodged, posing a risk of harm to patients during surgery, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling the Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters, specifically the CPB Catheter Kit-DR Gerhardt. The recall involves 53,139 units distributed worldwide, including nationwide in the United States and in various international locations.
The recall was initiated because Terumo identified a foreign substance on the inner surface of some cannula tips during production. A preliminary investigation determined that this substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process, though its exact composition is not specified in the source text.
These devices are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, vent the left heart, and aspirate air from the aorta during cardiopulmonary bypass procedures. The affected catalog number is 80001-02, and the specific lot numbers are NP20 and PA16.
The recalled product
- Product
- CPB CATHETER KIT-DR GERHARDT Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Category
- Medical Device — Cardiovascular
- Affected units
- 53,139
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog number: 80001-02 and lot number: NP20 and PA16.
Distribution
Part of a larger recall action
This product is one of 20 recalled by Terumo Cardiovascular Systems Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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